(Senior) Regulatory Affairs Specialist

Are you a meticulous and detail-oriented professional with a deep understanding of regulatory frameworks? Do you thrive in a fast-paced, ever-evolving industry where compliance is key? Look no further! We are searching for an exceptional (Senior) Regulatory Affairs Specialist to join our passionate team. 

Working with us you will receive: 

• a chance to develop yourself in a Polish-Danish culture based on openness and trust; 
• the opportunity to exchange experiences and develop skills in an international environment; 
• a full introductory training; 
• the possibility to learn the essential standards and regulations e.g. (EU) 2017/745, FDA 21CFR820, and many more; 
• full-time work agreement in the international developing organization; 
• flexible working hours and hybrid workplace; 
• possibility to improve English in daily basis (courses offered). 

What tasks are waiting for you? 

• Ensure that regulatory requirements are fulfilled for medical device products. 
• Coordinate and compile regulatory files to ensure registrations and renewals within the allocated registration projects. 
• Maintain registrations in defined areas to ensure regulatory compliance. 
• Ensure that the Regulatory Affairs System is updated and data are validated. 
• Support the organization in relation to Regulatory Affairs related issues. 
• Cooperate with notifying body and quality during audits. 

It would be great if you have:  

• A bachelor’s or master’s degree in audiology, health care, life science, engineering or other relevant technical or scientific degree; 
• Min 1-year experience with regulatory activities within medical devices and/or other regulatory environment; 
• Knowledge of directives, standards and guidelines within the regulatory medical device area and/or other related regulatory areas (e.g. MDR, ISO 13495); 
• Proficient in English – written and spoken; 
• Strong written and verbal communications skills. 

In the position of (Senior) Regulatory Affairs Specialist, you will work closely with Laura Bednarz, your direct supervisor.  

If you have more questions, please contact our recruiter Kasia: kmas@dgs-diagnostics.com  

Furthermore, we would like to inform you that the company has an internal reporting procedure, which is available at: demantcompliance - Make a report (codeofconduct.app) 

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